Proposed Rules. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-08934 · Docket No. FDA-2024-D-0083 · 21 CFR 809

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.” In the context of emergent situations involving chemical, biological, radiological, or nuclear (CBRN) threats, there may be a public health need for certain in vitro diagnostic devices (IVDs) to be available for immediate response purposes. When finalized, this guidance will describe the Agency's enforcement policy for certain laboratory manufacturers offering certain unauthorized IVDs for immediate response to CBRN agents in the absence of a declaration applicable to IVDs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance is not final nor is it for implementation at this time.

Dates

Submit either electronic or written comments on the draft guidance by July 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background When finalized, this guidance will describe the Agency's enforcement policy for certain laboratory manufacturers offering certain unauthorized IVDs for immediate response to CBRN agents in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as an “applicable 564 declaration”). 1 In the context of emergent situations involving CBRN threats, there may be a public health need for certain IVDs to be available for immediate response purposes. An emergent situation is, for purposes of this guidance, the period of time between detection of the exposure or outbreak and, either, resolution of the exposure or outbreak or issuance of an applicable 564 declaration. In the past, during this period of time, laboratory manufacturers offered laboratory developed tests (LDTs) for which FDA has had a general enforcement discretion approach. However, as discussed in the preamble to the final rule amending FDA regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory (LDT Final Rule), 2 FDA is phasing out this general enforcement discretion approach for LDTs. Accordingly, FDA is issuing this guidance with our enforcement policy for “immediate response” tests. 1 The Office of the Federal Register has published this document under the category “Proposed Rule” pursuant to its interpretation of 1 CFR 5.9(b). We note that the categorization as such for purposes of publication in the Federal Register does not affect the content or intent of the document. See 1 CFR 5.1(c). 2 “Medical Devices: Laboratory Developed Tests” is issued elsewhere in this Federal Register . This guidance, when finalized, will describe the Agency's enforcement policy for certain laboratory manufacturers offering certain unauthorized IVDs for immediate response to CBRN agents in the absence of an applicable 564 declaration. FDA does not intend to object to the offering of “immediate response” tests, as defined in the guidance, when the test is manufactured and offered by certain laboratory manufacturers, the test has been appropriately validated, FDA is notified, appropriate transparency is provided, the test is labeled for prescription use only, and there is no applicable 564 declaration, as described in the guidance. Prior to an emergent situation and after an emergent situation has been resolved, when there might not be a critical need for a coordinated and immediate public health response and where the implications of false results may not have as serious implications for public health decision-making, such tests may fall within the enforcement discretion policies described in section V.B of the preamble to the LDT Final Rule. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007032 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic OMB control No. “Emergency Use Authorization of Medical Products and Related Authorities” Emergency Use Authorization 0910-0595 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 814, subpart H Humanitarian Use Devices; Humanitarian Device Exemption 0910-0332 812 Investigational Device Exemption 0910-0078 860, subpart D De Novo classification process 0910-0844 “Administrative Procedures for CLIA Categorization” and “Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” CLIA Administrative Procedures; CLIA Waivers 0910-0607 800, 801, 809, and 830 Medical Device Labeling Regulations; Unique Device Identification 0910-0485 803 Medical Device Reporting 0910-0437 810 Recalls 0910-0432 Dated: April 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-08934 Filed 4-29-24; 8:45 am]